Events

Recall of Device Recall VAMP Jr

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences AG.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52802
  • Event Risk Class
    Class 2
  • Event Number
    Z-1934-2009
  • Event Initiated Date
    2008-03-14
  • Event Date Posted
    2009-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84035
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Continuous flush catheter. - Product Code KRA
  • Reason
    Edwards lifescience initiated a recall of on edwards "vamp jr" pressure monitoring products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "vamp jr" to become disconnected.
  • Action
    Edwards initiated the recall in the U.S. via a Urgent Customer lNotification letter with attached response confirmation fax-back attachment dated March 10, 2008 and was sent by Federal Express on March 12, 2008 requesting that customers cease using all "VAMP Jr" products and that they return all unused product. Customers were instructed to fax-back the confirmation attachment to 800-422-9329 and contact Edwards Customer service at 888-570-4012 to arrange for return of any unused product and obtain information about replacement product. Edwards Lifesciences requested that the customer provide written verification of stock and identify and unused product to be returned. This will enable a 100% effectiveness check for this recall. For product that was shipped to distributors, contact was made directly from Edwards Lifesciences Corporate Office in Irvine, CA. All product that was distributed internationally will be handled regionally. (i.e. US, Canada, Europe/EMEA, Japan, Intercontinental-including Latin America and Asia Pacific)

Device

Device Recall VAMP Jr
  • Model / Serial
    Lot numbers:Product manufactured between 8/01/06 and 2/29/08; Product Codes: C7217C3A, C7217C6A, PXVJ0441, PXVJ0705, PXVJ0711, PXVJ0819, PXVJ084, PXVJ0926, PXVJ0993, PXVJ356, T005071A, T100802A, T100803A, T391R00A, T430168A, T430169A, T432902A, T440Z01A, T443952B, T450552C, T450553A, T463403A, T470228C, T470411B, VMP306, VMP306PX, VMP406, VMP406PX, VMP426, VMP426PX, VMP448, VMP448PX
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and the countries of Australia, Austria, Belgium, Brazil, Canada, Canaric Island (Spain), China, Columbia, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Kuwait, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, Turkey, and United Kingdom.
  • Product Description
    Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Management Protection system), Lot numbers (all product manufactured between 8/01/06 and 2/29/08.)
  • Manufacturer
    Edwards Lifesciences AG

Manufacturer

Edwards Lifesciences AG
  • Manufacturer Address
    Edwards Lifesciences AG, Parque Industrial Itabo, Km. 18.5 Carr. Sanchez, Haina, San Cristobal Dominican Republic
  • Source
    USFDA